MAUDE Adverse Event Report: MEDTRONIC NAVIGATION, INC. (LOUISVILLE) INTERBODY INSERTER CAPSTONE & CLYDESDALE; ORTHOPEDIC STEREOTAXIC INSTRUMENT

Catalog Number 9734456

Device Problems Break (1069); Mechanical Problem (1384); Device Operates Differently Than Expected (2913)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 12/15/2017

Event Type  malfunction  

Manufacturer Narrative

Patient information was unavailable from the site.Device manufacturing date is unavailable at this time.No parts have been received by the manufacturer for evaluation.Part not returned for analysis.

Event Description

A medtronic representative reported that while in a sacroiliac and thoracolumbar procedure the inserter broke while trying to manipulate the implant in-situ.The site had another inserter that was used to get the implant where it needed to be.There was no impact on the patient outcome.

Manufacturer Narrative

Additional information: device manufacture date provided.Correction: unique device identification (udi) updated to proper value.The suspect instrument was returned to the manufacturer for evaluation.Testing found that a tab on the inserter was missing.The hardware investigation found that the reported event was related to a hardware issue.This issue was documented in a medtronic navigation hardware anomaly tracking database.

Manufacturer Narrative

Additional procedure information received.

Event Description

Re-positioning the implant took approximately 5 minutes once the new inserter was selected.

Manufacturer Narrative

Patient information received.

• Brand Name: INTERBODY INSERTER CAPSTONE & CLYDESDALE
• Type of Device: ORTHOPEDIC STEREOTAXIC INSTRUMENT
• Manufacturer (Section D): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer (Section G): MEDTRONIC NAVIGATION, INC. (LOUISVILLE); 826 coal creek circle; louisville CO 80027
• Manufacturer Contact: stephanie riley ; navigation customer quality; 826 coal creek circle; louisville, CO 80027-9710 ; 7635267745
• MDR Report Key: 7184111
• MDR Text Key: 97063604
• Report Number: 1723170-2018-00196
• Device Sequence Number: 1
• Product Code: OLO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K131425
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Medical Equipment Company Technician/Representative
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 08/01/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Physician
• Device Catalogue Number: 9734456
• Device Lot Number: 130708
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/18/2018
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/15/2017
• Initial Date FDA Received: 01/11/2018
• Supplement Dates Manufacturer Received: 01/18/2018; 03/09/2018; 08/01/2018
• Supplement Dates FDA Received: 02/08/2018; 03/18/2018; 08/01/2018
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/08/2013
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 60 YR
• Patient Weight: 64